11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REDEMPTION Beaming System
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517629784·CoRoent Ant TLIF Ti, 12x11x34mm 12°
BD BBL™ Phenylalanine Agar Slants
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902213421·Tube Phenylalanine Agar Slants 10 Ea
Sklar®
FDA UDI
SKLAR CORPORATION·10649111362484·STEVENS TENOT DEL CVD BB 4 1/2
NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
XIA 4.5 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 3, 2014
PHILIPS INFORMATION CENTER
FDA Adverse Event
Death
·PHILIPS HEALTHCARE - ANDOVER·Product code MHX·August 17, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013
XIA TITANIUM 4.5 BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code NKB·September 3, 2020
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024